Official Title: “Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy”

With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: Saline
  • Saline 5 ml administrated intravenously
• Drug: Opioid
  • Butorphanol tartrate 1 mg i.v.
• Drug: Opioid
  • Butorphanol Tartrate 2 mg i.v.
• Drug: NSAID
  • Flurbiprofen Axetil 50 mg i.v.
• Drug: NSAID
  • Flurbiprofen Axetil 100 mg i.v.
• Drug: Opioid
  • Tramadol Hydrochloride 10 mg i.v.
• Drug: Opioid
  • Tramadol Hydrochloride 20 mg i.v.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: I
  • No drug was delivered.
• Active Comparator: II
  • Butorphanol tartrate 1mg was given intravenously.
• Active Comparator: III
  • Butorphanol tartrate 2 mg was given intravenously.
• Active Comparator: IV
  • Flurbiprofen Axetil 50 mg was given intravenously.
• Active Comparator: V
  • Flurbiprofen Axetil 100 mg was given intravenously.
• Active Comparator: VI
  • Tramadol Hydrochloride 10 mg was given intravenously.
• Active Comparator: VII
  • Tramadol Hydrochloride 20 mg was given intravenously.

Primary Measures

• Visual analog scale (VAS) rating of pain
  • Time Frame: 0-24h after surgeries
    Safety Issue?: Yes

Secondary Measures

• VAS rating of sedation
  • Time Frame: 0h to 24h after the end of the operation
    Safety Issue?: Yes
• Overall VAS rating of satisfaction with analgesia
  • Time Frame: 24 h after operation
    Safety Issue?: Yes
• Incidence of side effects
  • Time Frame: From the initiation of analgesia (0 h) to the end of the study (24 h postoperative)
    Safety Issue?: Yes

Inclusion Criteria:

• Chinese
• No cardiac and pulmonary diseases
• ASA I-II
• No alcohol drinking.

Exclusion Criteria:

• <19yrs, and >65yrs
• History of central active drugs administration
• Drug abuse
• Hypertension
• Diabetes
• Any other chronic diseases.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nanjing Medical University

Overall Clinical Trial Officials and Contacts

XiaoFeng Shen, MD Study Chair Nanjing Medical University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00519246

Study ID Number: NMU-2579-4FW

ClinicalTrials.gov Identifier: NCT00519246

Health Authority: China: Ministry of Health